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Post by mnholdem on May 3, 2016 6:20:59 GMT -5
NOTE: This article was published in 2013 before the FDA approved Afrezza
Inhalable Insulin — A Breathtaking Development Chris Leach | Insulin Nation - March 28th 2013
Excerpt:
The AFREZZA saga reads like a movie script. A brilliant innovator/CEO discovers a small company with technology that he thinks could revolutionize the development, use and absorption speed of man-made insulin. He sells his existing diabetes business to a giant conglomerate for billions and sets out to commercialize his new product, which didn’t fit with the conglomerate’s business model. He invests close to a billion dollars of his own money, suffers from the backlash of a pharma giant’s failed attempt to market what was considered to be a somewhat similar treatment approach, is denied FDA approval not once, but twice — the second time under somewhat mysterious circumstances — and and finally, wins approval for a therapy that would benefit millions of people with diabetes.
Hollywood might reject the storyline as unrealistic, which only goes to prove that truth is stranger than fiction, because this, in a nutshell, is the tale of Al Mann and AFREZZA.
Source: insulinnation.com/treatment/inhalable-insulin-a-breathtaking-development/
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Post by sportsrancho on May 3, 2016 7:23:20 GMT -5
Awesome, I posted on Twitter.
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Post by lakon on May 3, 2016 12:40:00 GMT -5
FTA: "it [ MNKD] built a plant to manufacture the product [Afrezza] in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA. The leftover Exubera insulin is currently stored in Germany." People were asking what the benefit of getting other insulin approved besides the AMPH insulin. $10 billion is an answer worth noting to those who forgot. MNKD does have assets that do not show up on their balance sheet as noted before. Just something to think about when the market is valuing the company around $600 million or so. Also, for agedhippie, you might consider the potential of generic regular insulin by a Chinese company to be a bit more important in this context. Cheaper API means cheaper Afrezza. mnkd.proboards.com/post/68155/thread |
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Post by agedhippie on May 3, 2016 14:23:33 GMT -5
FTA: "it [ MNKD] built a plant to manufacture the product [Afrezza] in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA. The leftover Exubera insulin is currently stored in Germany." People were asking what the benefit of getting other insulin approved besides the AMPH insulin. $10 billion is an answer worth noting to those who forgot. MNKD does have assets that do not show up on their balance sheet as noted before. Just something to think about when the market is valuing the company around $600 million or so. Also, for agedhippie , you might consider the potential of generic regular insulin by a Chinese company to be a bit more important in this context. Cheaper API means cheaper Afrezza. Cheap Regular insulin has existed for at least the last 10 years in Asia - once you get to a street cost of $3 a 10mL vial it's difficult to get much lower. The problem is that Mannkind signed a contract with Amphastar which has a two year notice period and minimum annual purchases so that's where they are getting their insulin, not any Chinese pharma or Pfizer (and I am happy with that as I am more comfortable with the quality control). As to the Pfizer insulin - the reason it is not on the balance sheet is because it was an option and not a sale. From the relevant Mannkind 8-K: On June 19 , 2009, MannKind Corporation (the “Company”) completed its acquisition from Pfizer Inc. (“Pfizer”) and its wholly owned subsidiary, Pfizer Manufacturing Frankfurt GmbH (the “Seller”), of a portion of the Seller’s inventory of bulk insulin and the Seller’s and Pfizer’s rights under a license to manufacture insulin for pulmonary delivery pursuant to that certain Insulin Sale and Purchase Agreement between the Company, Pfizer and the Seller dated March 6, 2009 (the “Insulin Agreement”). In accordance with the terms of the Insulin Agreement, on June 19 , 2009, the Company, Pfizer and the Seller also entered into an Insulin Maintenance and Call-Option Agreement (the “Option Agreement”) pursuant to which the Company agreed to maintain and store the remainder of the Seller’s bulk insulin inventory (the “ Retained Insulin ” ) and acquired an option to purchase the Retained Insulin, in whole or in part, at a specified price, to the extent that the Seller has not otherwise disposed of or used the Retained Insulin. The total purchase price for this transaction including consideration payable to the Company for the storage and maintenance of the Retained Insulin was $3 million, which the Company paid in cash.So for $3 million Mannkind bought some insulin which it probably used to manufacture the Afrezza used in the trials, and the right to buy the insulin at an agreed price provided Pfizer have not already sold it or used it. Any insulin purchased would be reflected on the balance sheet, and Mannkind are on the hook for the storage costs of the entire stockpile. So no $10 billion off balance sheet asset. |
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Post by lakon on May 3, 2016 15:07:37 GMT -5
FTA: "it [ MNKD] built a plant to manufacture the product [Afrezza] in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA. The leftover Exubera insulin is currently stored in Germany." People were asking what the benefit of getting other insulin approved besides the AMPH insulin. $10 billion is an answer worth noting to those who forgot. MNKD does have assets that do not show up on their balance sheet as noted before. Just something to think about when the market is valuing the company around $600 million or so. Also, for agedhippie , you might consider the potential of generic regular insulin by a Chinese company to be a bit more important in this context. Cheaper API means cheaper Afrezza. Cheap Regular insulin has existed for at least the last 10 years in Asia - once you get to a street cost of $3 a 10mL vial it's difficult to get much lower. The problem is that Mannkind signed a contract with Amphastar which has a two year notice period and minimum annual purchases so that's where they are getting their insulin, not any Chinese pharma or Pfizer (and I am happy with that as I am more comfortable with the quality control). As to the Pfizer insulin - the reason it is not on the balance sheet is because it was an option and not a sale. From the relevant Mannkind 8-K: On June 19 , 2009, MannKind Corporation (the “Company”) completed its acquisition from Pfizer Inc. (“Pfizer”) and its wholly owned subsidiary, Pfizer Manufacturing Frankfurt GmbH (the “Seller”), of a portion of the Seller’s inventory of bulk insulin and the Seller’s and Pfizer’s rights under a license to manufacture insulin for pulmonary delivery pursuant to that certain Insulin Sale and Purchase Agreement between the Company, Pfizer and the Seller dated March 6, 2009 (the “Insulin Agreement”). In accordance with the terms of the Insulin Agreement, on June 19 , 2009, the Company, Pfizer and the Seller also entered into an Insulin Maintenance and Call-Option Agreement (the “Option Agreement”) pursuant to which the Company agreed to maintain and store the remainder of the Seller’s bulk insulin inventory (the “ Retained Insulin ” ) and acquired an option to purchase the Retained Insulin, in whole or in part, at a specified price, to the extent that the Seller has not otherwise disposed of or used the Retained Insulin. The total purchase price for this transaction including consideration payable to the Company for the storage and maintenance of the Retained Insulin was $3 million, which the Company paid in cash.So for $3 million Mannkind bought some insulin which it probably used to manufacture the Afrezza used in the trials, and the right to buy the insulin at an agreed price provided Pfizer have not already sold it or used it. Any insulin purchased would be reflected on the balance sheet, and Mannkind are on the hook for the storage costs of the entire stockpile. So no $10 billion off balance sheet asset. You know what you know. You don't know what you don't know. Words to live by. LOL.  The reason MNKD had to deal with AMPH is because they used what became AMPH insulin in their trials as the approved API in Afrezza. Both MNKD and AMPH have stated this fact many times. That's why AMPH bought the insulin factory after approval to position for strength in negotiating with MNKD. The contract is not exclusive, and MNKD already told AMPH that they are not exercising the option for 2016. Of course, MNKD has plenty of AMPH insulin for a while, too, probably enough to last until they get the Pfizer insulin approved. Either way, they want AMPH insulin as part of the picture. It's a long-term play, nothing to worry about...same about the Chinese... MNKD maintains and stores the insulin in cryo for themselves and Pfizer. Go back and look at the historical documents. It was a ton of insulin that is MNKD's. Due to certain accounting principles, it showed up as an expense, not an asset, and disappeared. This fact was addressed a few years ago at an annual shareholders meeting by interested parties. MNKD has always been very coy about it. Note that is street value of the insulin as manufactured as Afrezza. So yes, effectively, a $10 billion off balance sheet "asset", or value, if MNKD continues as a going concern selling Afrezza at street prices. Since it was already an expense, they could eventually sell Afrezza at considerably lower costs and still have their cash flow improve dramatically. If MNKD gives up, the insulin has little to no value without an acquirer to continue the battle. I'm more interested in the former than the latter. |
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Post by agedhippie on May 3, 2016 17:21:11 GMT -5
Cheap Regular insulin has existed for at least the last 10 years in Asia - once you get to a street cost of $3 a 10mL vial it's difficult to get much lower. The problem is that Mannkind signed a contract with Amphastar which has a two year notice period and minimum annual purchases so that's where they are getting their insulin, not any Chinese pharma or Pfizer (and I am happy with that as I am more comfortable with the quality control). As to the Pfizer insulin - the reason it is not on the balance sheet is because it was an option and not a sale. From the relevant Mannkind 8-K: On June 19 , 2009, MannKind Corporation (the “Company”) completed its acquisition from Pfizer Inc. (“Pfizer”) and its wholly owned subsidiary, Pfizer Manufacturing Frankfurt GmbH (the “Seller”), of a portion of the Seller’s inventory of bulk insulin and the Seller’s and Pfizer’s rights under a license to manufacture insulin for pulmonary delivery pursuant to that certain Insulin Sale and Purchase Agreement between the Company, Pfizer and the Seller dated March 6, 2009 (the “Insulin Agreement”). In accordance with the terms of the Insulin Agreement, on June 19 , 2009, the Company, Pfizer and the Seller also entered into an Insulin Maintenance and Call-Option Agreement (the “Option Agreement”) pursuant to which the Company agreed to maintain and store the remainder of the Seller’s bulk insulin inventory (the “ Retained Insulin ” ) and acquired an option to purchase the Retained Insulin, in whole or in part, at a specified price, to the extent that the Seller has not otherwise disposed of or used the Retained Insulin. The total purchase price for this transaction including consideration payable to the Company for the storage and maintenance of the Retained Insulin was $3 million, which the Company paid in cash.So for $3 million Mannkind bought some insulin which it probably used to manufacture the Afrezza used in the trials, and the right to buy the insulin at an agreed price provided Pfizer have not already sold it or used it. Any insulin purchased would be reflected on the balance sheet, and Mannkind are on the hook for the storage costs of the entire stockpile. So no $10 billion off balance sheet asset. You know what you know. You don't know what you don't know. Words to live by. LOL. The reason MNKD had to deal with AMPH is because they used what became AMPH insulin in their trials as the approved API in Afrezza. Both MNKD and AMPH have stated this fact many times. That's why AMPH bought the insulin factory after approval to position for strength in negotiating with MNKD. The contract is not exclusive, and MNKD already told AMPH that they are not exercising the option for 2016. Of course, MNKD has plenty of AMPH insulin for a while, too, probably enough to last until they get the Pfizer insulin approved. Either way, they want AMPH insulin as part of the picture. It's a long-term play, nothing to worry about...same about the Chinese... MNKD maintains and stores the insulin in cryo for themselves and Pfizer. Go back and look at the historical documents. It was a ton of insulin that is MNKD's. Due to certain accounting principles, it showed up as an expense, not an asset, and disappeared. This fact was addressed a few years ago at an annual shareholders meeting by interested parties. MNKD has always been very coy about it. Note that is street value of the insulin as manufactured as Afrezza. So yes, effectively, a $10 billion off balance sheet "asset", or value, if MNKD continues as a going concern selling Afrezza at street prices. Since it was already an expense, they could eventually sell Afrezza at considerably lower costs and still have their cash flow improve dramatically. If MNKD gives up, the insulin has little to no value without an acquirer to continue the battle. I'm more interested in the former than the latter. I read the historical documents, both the 8-K that filing came from and the sale agreement. If there is anything else I would be interested. |
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Post by cm5 on May 3, 2016 19:05:30 GMT -5
Chris Leach----
Insulin Nation insulinnation.com/treatment/inhalable-insulin-a-breathtaking-development/
Chris Leach was the founding editor of numerous diabetes publications, including Insulin Nation, Type 2 Nation, and Health Matters. A lifelong entrepreneur, he also founded New Jersey Monthly and was part of the team that created ESPN, the Magazine. Chris passed away in 2013. Published by Chris Leach:
The Mouse Trap, 18 Nov 2013 in Cure Insight & Treatment Easier Pens For 2014?, 15 Nov 2013 in Research & Wearables/Products Tandem and the Future of Pumps, 23 Oct 2013 in Pumps Daily Pill May Help T1s Lower A1c and Reduce Insulin Use, 15 Oct 2013 in Medicine/Drugs & Treatment Artificial Pancreas: What’s in a Name?, 04 Oct 2013 in Artificial Pancreas Medtronic’s “Artificial Pancreas” Gains FDA Approval, 02 Oct 2013 in Artificial Pancreas A Simpler Approach To Treating Hypos, 27 Sep 2013 in Hypoglycemia RIP, A1cNow, 25 Sep 2013 in Meters & CGMs Good Vibrations: A New Approach to Treating Neuropathy, 19 Sep 2013 in Treatment & Wearables/Products A Memorable App, 11 Sep 2013 in Pumps
Back to the Future for Cancer Drug That May Help Type 1s, 05 Sep 2013 in Medicine/Drugs The Cure is in Us, 03 Sep 2013 in Cure Insight Afrezza Enters the Home Stretch…Again, 22 Aug 2013 in Medicine/Drugs Better Math, Smarter Meters, 15 Aug 2013 in Meters & CGMs Test Strip Accuracy: Blood In, Garbage Out?, 01 Aug 2013 in Meters & CGMs
Sleep Apnea in Kids: A Total Nightmare, 30 Jul 2013 in Living & Treatment A New Role For “Misplaced Parents?”, 19 Jul 2013 in Living & Treatment Harnessing Hypos: Glucagon As An Everyday Tool, 17 Jul 2013 in Hypoglycemia Pumping Glucagon: The Unusual Case of Randy Brown, 16 Jul 2013 in Hypoglycemia ADA Scientific Sessions 2013: A Pause Before The “Next Big Thing”, 27 Jun 2013 in Cure Insight & Medicine/Drugs & Wearables/Products insulinnation.com/author/chris-leach/
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Post by lakon on May 4, 2016 9:34:09 GMT -5
You know what you know. You don't know what you don't know. Words to live by. LOL. The reason MNKD had to deal with AMPH is because they used what became AMPH insulin in their trials as the approved API in Afrezza. Both MNKD and AMPH have stated this fact many times. That's why AMPH bought the insulin factory after approval to position for strength in negotiating with MNKD. The contract is not exclusive, and MNKD already told AMPH that they are not exercising the option for 2016. Of course, MNKD has plenty of AMPH insulin for a while, too, probably enough to last until they get the Pfizer insulin approved. Either way, they want AMPH insulin as part of the picture. It's a long-term play, nothing to worry about...same about the Chinese... MNKD maintains and stores the insulin in cryo for themselves and Pfizer. Go back and look at the historical documents. It was a ton of insulin that is MNKD's. Due to certain accounting principles, it showed up as an expense, not an asset, and disappeared. This fact was addressed a few years ago at an annual shareholders meeting by interested parties. MNKD has always been very coy about it. Note that is street value of the insulin as manufactured as Afrezza. So yes, effectively, a $10 billion off balance sheet "asset", or value, if MNKD continues as a going concern selling Afrezza at street prices. Since it was already an expense, they could eventually sell Afrezza at considerably lower costs and still have their cash flow improve dramatically. If MNKD gives up, the insulin has little to no value without an acquirer to continue the battle. I'm more interested in the former than the latter. I read the historical documents, both the 8-K that filing came from and the sale agreement. If there is anything else I would be interested. Well, in that case, it is easier if you just listen to Al Mann. It is a bit esoteric and competition sensitive if you are looking for textual documentation. You'd have to know the lay of the land back when MannKind, Nektar, Pfizer, Sanofi, Merck, Lilly, and Novo were playing games together, jockeying for position. I prefer the KISS principle. In context, listen to what Al said in 2014. There are a lot of caveats to how one calculates the asset value, but the estimate from the article stands as one example. Note that the dry powder hexameric regular insulin as monomeric Afrezza could be worth a lot less or a lot MORE so $10 billion is not bad. Also, that's not revenue. Listen and enjoy! (I might move this to its own thread as it comes up from time to time...) www.youtube.com/watch?v=8PcEHw5P71Y&t=41m17s |
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